Diabetes, Obesity
Conditions
Brief summary
The purpose of this study is to determine how certain types of bacteria in the human gut may affect weight gain, and contribute to the development of diabetes. The investigators initial studies have shown that gut bacteria that produce methane may directly affect weight gain. These bacteria, called methanogens, produce methane gas as a byproduct, which can be detected through breath testing. Methane can slow the passage of food through the intestines, which would allow extra time for uptake and absorption of nutrients and calories, and might contribute to weight gain. The investigators have also found that people who have increased levels of methane-producing bacteria in their intestines also have higher levels of glucose in their blood. Therefore, control of how the body responds to insulin and uses glucose may be altered in methane-producing individuals. This research study is designed to test the investigational use of the drugs neomycin and rifaximin that have been approved by the U.S Food and Drug Administration (FDA). While neomycin is FDA-approved for treating skin infections, preparing the bowel for surgery, and hepatic encephalopathy (a condition that occurs when a damaged liver cannot remove the toxins that a healthy liver normally would), and rifaximin is FDA-approved for treating travelers' diarrhea, they are not yet approved to be used together for the treatment of methanogens or obesity.
Detailed description
Pre-diabetes is defined by impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) and affects more than 40% of US adults. While glycemic dysregulation and insulin resistance are central to the progression from pre-diabetes to diabetes, obesity also plays a key role. Research has begun to define the relationship between gut flora, metabolism and weight gain. Animal studies have linked a specific methanogen, Methanobrevibacter smithii, to weight gain, and in humans we have found that increased methane on breath test is associated both with increased body mass index (BMI) and higher blood glucose levels. We also found that methane gas directly slows gut transit by 59% in an in vivo animal model. We hypothesize that this slowing of transit could result in a greater time to harvest nutrients and absorb calories, representing a potential mechanism for elevated post-prandial glycemic excursions and weight gain. In this study, we will test this hypothesis by determining the effects of enteric methane production on glucose excursions, gut transit and energy utilization in obese or overweight, prediabetic, adult subjects. We will explore the relationship between methane, M. smithii, obesity and gut transit in human subjects using objective measures of metabolic function, glucose excursions, energy utilization and transit studies, to evaluate whether intestinal methane production is associated with a higher incidence of diabetes risk in an obese study population. We will then repeat testing following a course of antibiotics known to eliminate methanogens. This will potentially provide novel therapies for the pre-diabetic patient, and allow new avenues for research.
Interventions
DRUGNeomycin
Neomycin: 500mg po bid for 10 days
DRUGRifaximin
Rifaximin: 550mg po tid for 10 days
Sponsors
American Diabetes Association
Cedars-Sinai Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18-65 years old with pre-diabetes (hemoglobin a1c of 5.7-6.4%) * BMI \> 25.0 * presence of methane on a breath sample (\>3ppm)
Exclusion criteria
Subjects will be excluded from the study if they exhibit any of the following: * Diabetes/diabetes medications * Prokinetic medication * Pregnancy * History of bariatric or intestinal surgery (other than cholecystectomy or appendectomy) * Unstable thyroid disease * An active weight loss treatment/plan * Smoking * Dietary restrictions (lactose intolerance, vegan etc) * Other inability to comply with the study procedures, including known allergy to the study antibiotics (neomycin and rifaximin) * Active inflammatory bowel disease (celiac, Crohn's disease, ulcerative colitis) * Antibiotic use in the past month * Subjects who do not have a microwave (for reheating study meals) and a freezer (for storing leftovers and stool samples) will be excluded from this study. * Subjects who have an aspirin sensitivity * Proton pump inhibitor medications or antacids * History of bezoar * Disorders of swallowing * Suspected strictures, fistulas or physiological GI obstruction * GI surgery within 3 months * Severe dysphagia to food or pills * Diverticulitis * Subjects who use an implanted or portable electromechanical device such as a cardiac pacemaker or infusion pump * Subject who have a peanut allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric Emptying | Baseline and 1-60 days following completion of antibiotic treatment | Gastric Emptying times (minutes) were determined in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment gastric emptying studies were performed within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) |
| Number of Subjects Who Eradicated Methane on Breath Test | Baseline and 1-14 days following completion of antibiotic treatment | Number of subjects who exhibited a decrease in breath methane levels to below detectable (below 3ppm) following antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment breath tests were performed within 2 weeks (14 days) of completing the course of antibiotics. |
| Stool Methanogen Levels | Baseline and 1-60 days following completion of antibiotic treatment | Stool methanogen levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment stool samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3) |
| Stool Total Bacteria Levels | Baseline and 1-60 days following completion of antibiotic treatment | Stool total bacteria levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics.Post-treatment stool samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3) |
| Low Density Lipoprotein (LDL) Levels Before and After Antibiotic Therapy | Baseline and 1-60 days following completion of antibiotic treatment | LDL levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment blood samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3) |
| Total Cholesterol Levels Before and After Antibiotic Therapy | Baseline and 1-60 days following completion of antibiotic treatment | Total cholesterol levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics.Post-treatment blood samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3) |
| Average Daily Caloric Loss in Stool | Baseline and 1-60 days following completion of antibiotic treatment | The daily caloric loss in stool for each subject was calculated by expressing the total number of kcalories lost in stool over a 3-day period as a percentage of the total number of kcalories ingested over the same 3 days (the number of calories ingested = the number available in meals provided less the number remaining in leftovers). Caloric content for meals, leftovers, and stool was determined by bomb calorimetry. This average daily caloric loss for each group was then compared before and after antibiotic therapy. Post-treatment caloric harvest studies were performed within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bowel Symptoms - Abdominal Pain | Baseline and 1-60 days following completion of antibiotic treatment | Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) |
| Bowel Symptoms - Constipation | Baseline and 1-60 days following completion of antibiotic treatment | Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) |
| Bowel Symptoms - Diarrhea | Baseline and 1-60 days following completion of antibiotic treatment | Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) |
| Bowel Symptoms - Straining | Baseline and 1-60 days following completion of antibiotic treatment | Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) |
| % Stool Dry Weight | Baseline and 1-60 days following completion of antibiotic treatment | % stool dry weight \[total stool dry weight (g)/total stool fresh weight (g)\] was determined in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment stool samples were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) |
| Bowel Symptoms - Bloating | Baseline and 1-60 days following completion of antibiotic treatment | Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) |
Countries
United States
Participant flow
Recruitment details
Study was open for recruitment from April 12, 2012 - Dec 31, 2013 Setting: Tertiary care center
Pre-assignment details
A total of 12 subjects were consented to participate. 1 subject withdrew prior to completing the study.
Participants by arm
| Arm | Count |
|---|---|
| Obese/Overweight, Prediabetic Methane Positive Subjects Neomycin Rifaximin
Neomycin: Neomycin: 500mg po bid for 10 days
Rifaximin: Rifaximin: 550mg po tid for 10 days | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Obese/Overweight, Prediabetic Methane Positive Subjects |
|---|---|
| A1c (%) | 5.72 Percent STANDARD_DEVIATION 0.6 |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 47 years STANDARD_DEVIATION 9 |
| Body Mass Index (BMI) | 35.17 kg/m^2 STANDARD_DEVIATION 7.71 |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Average Daily Caloric Loss in Stool
The daily caloric loss in stool for each subject was calculated by expressing the total number of kcalories lost in stool over a 3-day period as a percentage of the total number of kcalories ingested over the same 3 days (the number of calories ingested = the number available in meals provided less the number remaining in leftovers). Caloric content for meals, leftovers, and stool was determined by bomb calorimetry. This average daily caloric loss for each group was then compared before and after antibiotic therapy. Post-treatment caloric harvest studies were performed within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)
Time frame: Baseline and 1-60 days following completion of antibiotic treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Obese/Overweight, Prediabetic Methane Positive | Average Daily Caloric Loss in Stool | Pre-treatment | 8.1 %kcal lost | Standard Deviation 2.7 |
| Obese/Overweight, Prediabetic Methane Positive | Average Daily Caloric Loss in Stool | Post-treatment | 8.3 %kcal lost | Standard Deviation 3.8 |
| Methane Non-Eradicators | Average Daily Caloric Loss in Stool | Pre-treatment | 8.3 %kcal lost | Standard Deviation 1.8 |
| Methane Non-Eradicators | Average Daily Caloric Loss in Stool | Post-treatment | 8.3 %kcal lost | Standard Deviation 3.8 |
Comparison: Values compared in methane eradicators only pre- and post-treatmentp-value: 0.97t-test, 2 sided
Comparison: Values compared in total study population pre- and post-treatmentp-value: 0.85t-test, 2 sided
Primary
Gastric Emptying
Gastric Emptying times (minutes) were determined in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment gastric emptying studies were performed within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)
Time frame: Baseline and 1-60 days following completion of antibiotic treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Obese/Overweight, Prediabetic Methane Positive | Gastric Emptying | Pre-treatment | 182.3 minutes | Standard Deviation 72.8 |
| Obese/Overweight, Prediabetic Methane Positive | Gastric Emptying | Post-treatment | 163.5 minutes | Standard Deviation 46.8 |
| Methane Non-Eradicators | Gastric Emptying | Pre-treatment | 174.9 minutes | Standard Deviation 71.1 |
| Methane Non-Eradicators | Gastric Emptying | Post-treatment | 164.9 minutes | Standard Deviation 45.8 |
Comparison: Values compared in methane eradicators only pre- and post-treatmentp-value: 0.61t-test, 2 sided
Comparison: Values compared in total study population pre- and post-treatmentp-value: 0.45t-test, 2 sided
Primary
Low Density Lipoprotein (LDL) Levels Before and After Antibiotic Therapy
LDL levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment blood samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3)
Time frame: Baseline and 1-60 days following completion of antibiotic treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Obese/Overweight, Prediabetic Methane Positive | Low Density Lipoprotein (LDL) Levels Before and After Antibiotic Therapy | Pre-treatment | 116 mg/dL | Standard Deviation 42 |
| Obese/Overweight, Prediabetic Methane Positive | Low Density Lipoprotein (LDL) Levels Before and After Antibiotic Therapy | Post-treatment | 104 mg/dL | Standard Deviation 46 |
| Methane Non-Eradicators | Low Density Lipoprotein (LDL) Levels Before and After Antibiotic Therapy | Pre-treatment | 96 mg/dL | Standard Deviation 41 |
| Methane Non-Eradicators | Low Density Lipoprotein (LDL) Levels Before and After Antibiotic Therapy | Post-treatment | 111 mg/dL | Standard Deviation 51 |
Comparison: P-value is comparing change in methane eradiacators before and after treatment to change in methane non-eradiacators before and after treatmentp-value: 0.028t-test, 2 sided
Primary
Number of Subjects Who Eradicated Methane on Breath Test
Number of subjects who exhibited a decrease in breath methane levels to below detectable (below 3ppm) following antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment breath tests were performed within 2 weeks (14 days) of completing the course of antibiotics.
Time frame: Baseline and 1-14 days following completion of antibiotic treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Obese/Overweight, Prediabetic Methane Positive | Number of Subjects Who Eradicated Methane on Breath Test | 8 participants |
Primary
Stool Methanogen Levels
Stool methanogen levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment stool samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3)
Time frame: Baseline and 1-60 days following completion of antibiotic treatment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Obese/Overweight, Prediabetic Methane Positive | Stool Methanogen Levels | Pre-treatment | 3.6*10^7 colony forming units |
| Obese/Overweight, Prediabetic Methane Positive | Stool Methanogen Levels | Post-treatment | 1.1*10^5 colony forming units |
| Methane Non-Eradicators | Stool Methanogen Levels | Pre-treatment | 6.86*10^8 colony forming units |
| Methane Non-Eradicators | Stool Methanogen Levels | Post-treatment | 9.4*10^7 colony forming units |
Comparison: Values compared in methane eradicators only pre- and post-treatmentp-value: 0.16t-test, 2 sided
Primary
Stool Total Bacteria Levels
Stool total bacteria levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics.Post-treatment stool samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3)
Time frame: Baseline and 1-60 days following completion of antibiotic treatment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Obese/Overweight, Prediabetic Methane Positive | Stool Total Bacteria Levels | Pre-treatment | 1.1*10^9 colony forming units |
| Obese/Overweight, Prediabetic Methane Positive | Stool Total Bacteria Levels | Post-treatment | 1.2*10^9 colony forming units |
| Methane Non-Eradicators | Stool Total Bacteria Levels | Pre-treatment | 3.7*10^8 colony forming units |
| Methane Non-Eradicators | Stool Total Bacteria Levels | Post-treatment | 8.5*10^9 colony forming units |
Primary
Total Cholesterol Levels Before and After Antibiotic Therapy
Total cholesterol levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics.Post-treatment blood samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3)
Time frame: Baseline and 1-60 days following completion of antibiotic treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Obese/Overweight, Prediabetic Methane Positive | Total Cholesterol Levels Before and After Antibiotic Therapy | Pre-treatment | 192 mg/dL | Standard Deviation 51 |
| Obese/Overweight, Prediabetic Methane Positive | Total Cholesterol Levels Before and After Antibiotic Therapy | Post-treatment | 177 mg/dL | Standard Deviation 52 |
| Methane Non-Eradicators | Total Cholesterol Levels Before and After Antibiotic Therapy | Pre-treatment | 173 mg/dL | Standard Deviation 41 |
| Methane Non-Eradicators | Total Cholesterol Levels Before and After Antibiotic Therapy | Post-treatment | 188 mg/dL | Standard Deviation 49 |
Comparison: P-value is comparing change in methane eradiacators before and after treatment to change in methane non-eradiacators before and after treatmentp-value: 0.01t-test, 2 sided
Secondary
Bowel Symptoms - Abdominal Pain
Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)
Time frame: Baseline and 1-60 days following completion of antibiotic treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Obese/Overweight, Prediabetic Methane Positive | Bowel Symptoms - Abdominal Pain | Pre-treatment | 23.36 0-100mm visual analogue scale | Standard Deviation 27.18 |
| Obese/Overweight, Prediabetic Methane Positive | Bowel Symptoms - Abdominal Pain | Post-treatment | 18.18 0-100mm visual analogue scale | Standard Deviation 29.91 |
| Methane Non-Eradicators | Bowel Symptoms - Abdominal Pain | Pre-treatment | 28.6 0-100mm visual analogue scale | Standard Deviation 30.3 |
| Methane Non-Eradicators | Bowel Symptoms - Abdominal Pain | Post-treatment | 21.6 0-100mm visual analogue scale | Standard Deviation 34.7 |
Comparison: Values compared in total study population pre- and post-treatmentp-value: 0.43t-test, 2 sided
Comparison: Values compared in methane eradicators only pre- and post-treatmentp-value: 0.44t-test, 2 sided
Secondary
Bowel Symptoms - Bloating
Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)
Time frame: Baseline and 1-60 days following completion of antibiotic treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Obese/Overweight, Prediabetic Methane Positive | Bowel Symptoms - Bloating | Pre-treatment | 55.09 0-100mm visual analogue scale | Standard Deviation 34.18 |
| Obese/Overweight, Prediabetic Methane Positive | Bowel Symptoms - Bloating | Post-treatment | 39.91 0-100mm visual analogue scale | Standard Deviation 33.27 |
| Methane Non-Eradicators | Bowel Symptoms - Bloating | Pre-treatment | 66.8 0-100mm visual analogue scale | Standard Deviation 32.4 |
| Methane Non-Eradicators | Bowel Symptoms - Bloating | Post-treatment | 38.9 0-100mm visual analogue scale | Standard Deviation 36.1 |
Comparison: Values compared in methane eradicators only pre- and post-treatmentp-value: 0.018t-test, 2 sided
Comparison: Values compared in total study population pre- and post-treatmentp-value: 0.14t-test, 2 sided
Secondary
Bowel Symptoms - Constipation
Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)
Time frame: Baseline and 1-60 days following completion of antibiotic treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Obese/Overweight, Prediabetic Methane Positive | Bowel Symptoms - Constipation | Pre-treatment | 30.18 0-100mm visual analogue scale | Standard Deviation 29.75 |
| Obese/Overweight, Prediabetic Methane Positive | Bowel Symptoms - Constipation | Post-treatment | 20.55 0-100mm visual analogue scale | Standard Deviation 33.9 |
| Methane Non-Eradicators | Bowel Symptoms - Constipation | Pre-treatment | 31.0 0-100mm visual analogue scale | Standard Deviation 30.5 |
| Methane Non-Eradicators | Bowel Symptoms - Constipation | Post-treatment | 22.3 0-100mm visual analogue scale | Standard Deviation 39.6 |
Comparison: Values compared in total study population pre- and post-treatmentp-value: 0.13t-test, 2 sided
Comparison: Values compared in methane eradicators only pre- and post-treatmentp-value: 0.25t-test, 2 sided
Secondary
Bowel Symptoms - Diarrhea
Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)
Time frame: Baseline and 1-60 days following completion of antibiotic treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Obese/Overweight, Prediabetic Methane Positive | Bowel Symptoms - Diarrhea | Pre-treatment | 23.73 0-100mm visual analogue scale | Standard Deviation 30.16 |
| Obese/Overweight, Prediabetic Methane Positive | Bowel Symptoms - Diarrhea | Post-treatment | 14.64 0-100mm visual analogue scale | Standard Deviation 31.01 |
| Methane Non-Eradicators | Bowel Symptoms - Diarrhea | Post-treatment | 17.3 0-100mm visual analogue scale | Standard Deviation 36 |
| Methane Non-Eradicators | Bowel Symptoms - Diarrhea | Pre-treatment | 30.5 0-100mm visual analogue scale | Standard Deviation 32.9 |
Comparison: Values compared in total study population pre- and post-treatmentp-value: 0.29t-test, 2 sided
Comparison: Values compared in methane eradicators only pre- and post-treatmentp-value: 0.27t-test, 2 sided
Secondary
Bowel Symptoms - Straining
Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)
Time frame: Baseline and 1-60 days following completion of antibiotic treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Obese/Overweight, Prediabetic Methane Positive | Bowel Symptoms - Straining | Pre-treatment | 31.64 0-100mm visual analogue scale | Standard Deviation 29.25 |
| Obese/Overweight, Prediabetic Methane Positive | Bowel Symptoms - Straining | Post-treatment | 21.55 0-100mm visual analogue scale | Standard Deviation 30.19 |
| Methane Non-Eradicators | Bowel Symptoms - Straining | Pre-treatment | 37.5 0-100mm visual analogue scale | Standard Deviation 31.8 |
| Methane Non-Eradicators | Bowel Symptoms - Straining | Post-treatment | 18.4 0-100mm visual analogue scale | Standard Deviation 34.5 |
Comparison: Values compared in total study population pre- and post-treatmentp-value: 0.22t-test, 2 sided
Comparison: Values compared in methane eradicators only pre- and post-treatmentp-value: 0.059t-test, 2 sided
Secondary
% Stool Dry Weight
% stool dry weight \[total stool dry weight (g)/total stool fresh weight (g)\] was determined in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment stool samples were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)
Time frame: Baseline and 1-60 days following completion of antibiotic treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Obese/Overweight, Prediabetic Methane Positive | % Stool Dry Weight | Pre-treatment | 24.1 % stool dry weight | Standard Deviation 5.3 |
| Obese/Overweight, Prediabetic Methane Positive | % Stool Dry Weight | Post-treatment | 22.9 % stool dry weight | Standard Deviation 4.4 |
| Methane Non-Eradicators | % Stool Dry Weight | Pre-treatment | 25.1 % stool dry weight | Standard Deviation 4.7 |
| Methane Non-Eradicators | % Stool Dry Weight | Post-treatment | 22.6 % stool dry weight | Standard Deviation 4.4 |
Comparison: Values compared in total study population pre- and post-treatmentp-value: 0.33t-test, 2 sided
Comparison: Values compared in methane eradicators only pre- and post-treatmentp-value: 0.075t-test, 2 sided